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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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S-ROM Total Hip System ZTT Oversize Proximal Sleeve POROUS COATED 24 F XXL FITS: 22 x 17 STEM Cone: F Triangle: XXL 22 INTERNAL DIAMETER
DEPUY ORTHOPAEDICS, INC.
55-0751
In Commercial Distribution

  • 10603295175650 ()
550751

  • Sleeve femoral/tibial extension, coated
S-ROM Total Hip System ZTT Oversize Proximal Sleeve POROUS COATED 24 F LRG FITS: 22 x 17 STEM Cone: F Triangle: LRG 22 INTERNAL DIAMETER
DEPUY ORTHOPAEDICS, INC.
55-0748
In Commercial Distribution

  • 10603295175643 ()
550748

  • Sleeve femoral/tibial extension, coated
S-ROM Total Hip System ZTT Oversize Proximal Sleeve POROUS COATED 22 F XXL FITS: 20 x 15 STEM Cone: F Triangle: XXL 20 INTERNAL DIAMETER
DEPUY ORTHOPAEDICS, INC.
55-0741
In Commercial Distribution

  • 10603295175629 ()
550741

  • Sleeve femoral/tibial extension, coated
S-ROM Total Hip System ZTT Oversize Proximal Sleeve POROUS COATED 22 F SML FITS: 20 x 15 STEM Cone: F Triangle: SML 20 INTERNAL DIAMETER
DEPUY ORTHOPAEDICS, INC.
55-0737
In Commercial Distribution

  • 10603295175605 ()
550737

  • Sleeve femoral/tibial extension, coated
S-ROM Total Hip System ZTT Oversize Proximal Sleeve POROUS COATED 20 F LRG FITS: 18 x 13 STEM Cone: F Triangle: LRG 18 INTERNAL DIAMETER
DEPUY ORTHOPAEDICS, INC.
55-0728
In Commercial Distribution

  • 10603295175582 ()
550728

  • Sleeve femoral/tibial extension, coated
S-ROM Total Hip System ZTT Oversize Proximal Sleeve POROUS COATED 18 F XXL FITS: 16 x 11 STEM Cone: F Triangle: XXL 16 INTERNAL DIAMETER
DEPUY ORTHOPAEDICS, INC.
55-0721
In Commercial Distribution

  • 10603295175568 ()
550721

  • Sleeve femoral/tibial extension, coated
S-ROM Total Hip System ZTT Oversize Proximal Sleeve POROUS COATED 18 F SML FITS: 16 x 11 STEM Cone: F Triangle: SML 16 INTERNAL DIAMETER
DEPUY ORTHOPAEDICS, INC.
55-0717
In Commercial Distribution

  • 10603295175544 ()
550717

  • Sleeve femoral/tibial extension, coated
The VisuMax laser keratome is a femtosecond laser. It generates a beam of ultra-short laser pulses which are guided through the aperture in the treatment objective . The optical system focuses the laser beam into the corneal tissue. The VisuMax femtosecond laser is indicated for use in ophthalmic surgery for the creation of corneal incisions in patients undergoing the following treatments: - In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea - In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea - In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty - In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting - Surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments. Additionally under class III: The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia with or without astigmatism • for spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters, • for cylinder from -0.75 diopters through -3.00 diopters, • when refraction spherical equivalent is no greater in magnitude than 10.00 diopters, in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of lower or equal 0.50 D in magnitude.
Carl Zeiss Meditec AG
VisuMax
In Commercial Distribution

  • 04049471095036 ()

  • Weight (basic unit) 470 kg
  • Weight (PSS): 250 kg
  • Weight (platform): 150 kg
  • L x W: 4.00 m x 3.70 m


  • Femtosecond ophthalmic solid-state laser system
Occluder, Internal Vessel, Temporary
GENZYME CORPORATION
LG250
Not in Commercial Distribution

  • 20358468019046 ()

  • one 2.5 mL syringe with 1 cannula (3.0 x 80 mm)
  • Total Volume: 2.5 Milliliter


  • Intravascular occluding solution kit
Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance (+) Lidocaine gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2, 30G x 1/2), and (3) two patient record labels
ANTEIS SA
8710M0S
In Commercial Distribution

  • 07640123791343 ()

  • Total Volume: 1.0 Milliliter
  • Needle Gauge: 27 Gauge
  • Needle Gauge: 30 Gauge


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
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